CFR TITLE 21, CHAPTER I, The 600 series covers

CFR TITLE 21, CHAPTER I, The 800 series are for ..........

Title 21 of the CFR is reserved for rules of the .........

TYPES OF SOLID ORAL DOSAGE FORMS

FACTORS AFFECTING IN VITRO DRUG PRODUCT DISSOLUTION

The dissolution rate generally decreases as the stirring rate or dissolution speed is increased.

The apparatus most commonly used for studying the dissolution of solid oral dosage forms. The basket at 100 rpm is commonly used for testing capsules and the paddle at 50 rpm for tablets.

The USP Apparatus 1 is paddle and USP Apparatus 2 is basket

For drugs that are weak acids, the dissolution rate increases with increasing pH, whereas, for weak bases, the dissolution rate decreases with increasing pH.

APPLICATIONS OF IN VITRO DISSOLUTION

Abbreviated new drug application (ANDA) is submitted to the FDA’s ..........

ANDA is termed “Abbreviated” because they generally need not include preclinical & clinical data to establish safety & effectiveness.

For ANDA, the BIOEQUIVALENCE (BE) is established when the ratio of Test/Reference of the PK parameters for rate (Cmax) , AUC of log transformed data meet the 90 % confidence intervals of 80 -125 %.

ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission.

What is the standard review time for a New Drug Application NDA?

How long does FDA, NDA priority review take?

Generic drug products must be both pharmaceutically equivalent and bio-equivalent to be considered therapeutically equivalent and therefore approvable.

The FDA recommends that in vivo bioequivalence studies be conducted in individuals that are representative of the general population, taking into account age, sex, and race factors.

Postapproval changes could potentially affect the identity, strength, quality, purity, and potency of the finished product and therefore must be fully evaluated before implementation to determine any impact on the finished product, as it may relate to safety or effectiveness.

The responsibility of an applicant does not end with approval of an NDA/ANDA the focus simply changes post-approval to ensuring approved drug products “remain” safe and effective and “accessible” to the public.

ADE means

Types of ADE Reports:

Post-marketing Surveillance means

Postmarketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug after it has been released on the market and is an important part of the science of pharmacovigilance

Outsourcing is the business practice of hiring a party outside a company to perform services and create goods that traditionally were performed in-house by the company's own employees and staff.

Bioavailability describes the concentration of drug in systemic blood in relation to the amount of drug given.

Bioequivalence: It is a relative term which denotes that the drug substance in two or more identical dosage form, reaches the systemic circulation at the same relative rate and to the same relative extent i.e; their plasma concentration-time profiles will be identical without significant statistical differences

Typical services outsourced for BA-BE studies:

CRO means